Plant Manufacturing Engineer - Sterile Fill

Plant Manufacturing Engineer – Sterile Fill

Location: Pleasant Prairie, WI – onsite

Contract

Department: Manufacturing/Engineering

Automated Systems, Inc. is looking for a Plant Manufacturing Engineer – Sterile Fill with at least 3 years of experience in manufacturing engineering within a pharmaceutical or sterile manufacturing environment to join the team at one of our global Pharmaceutical Manufacturing clients located in Kenosha, WI.

Job Summary:

The Plant Manufacturing Engineer will be responsible for supporting manufacturing operations in a sterile fill environment for prefilled syringes. This role ensures efficient operation, maintenance, and optimization of equipment, including spare parts management, calibration, and maintenance activities. The ideal candidate will also be responsible for assembling BOMs, developing equipment turnover packages, asset management, and writing Standard Operating Procedures (SOPs) to support manufacturing processes and compliance requirements.

Key Responsibilities:

· Support manufacturing operations for sterile fill of prefilled syringes, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards.

· Author and administer preventative maintenance procedures, including, developing and documenting preventative maintenance schedules for manufacturing equipment, and collaborating with maintenance and reliability teams to optimize preventative maintenance strategies.

· Work closely with maintenance teams to ensure proper calibration and upkeep of manufacturing equipment.

· Manage spare parts inventory, including identifying critical components, procurement, and tracking usage.

· Develop and maintain Bill of Materials (BOMs) for manufacturing equipment and processes.

· Prepare and execute equipment turnover packages, ensuring seamless integration of new and upgraded equipment.

· Author and revise Standard Operating Procedures (SOPs) to align with industry best practices and regulatory requirements.

· Collaborate with cross-functional teams, including Quality, Validation, and Production, to support process improvements and troubleshooting.

· Ensure documentation accuracy and compliance with FDA, ISO, and other relevant regulatory guidelines.

· Participate in continuous improvement projects to enhance safety, quality, and operational efficiency.

· Oversee asset management initiatives to ensure efficient tracking and utilization of manufacturing equipment.

Experience, Education & Skill Requirements:

· 3 years of experience in manufacturing engineering within a pharmaceutical or sterile manufacturing environment.

· Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field) or equivalent experience.

· Knowledge of sterile fill-finish operations, prefilled syringe manufacturing, and associated equipment is a plus.

· Experience in maintenance, calibration, and spare parts management.

· Excellent technical writing skills for SOP development and documentation.

· Proficiency with maintenance management software, ERP systems, and Microsoft Office Suite.

· Experience with asset management practices and tools.

· Knowledge of Blue Mountain RAM software for asset and maintenance management.